Impact of sirolimus-eluting stent fracture on 4-year clinical outcomes

Hisashi Umeda, Tomoko Kawai, Naoki Misumida, Tomoyuki Ota, Kazutaka Hayashi, Mitsunori Iwase, Hideo Izawa, Shigeo Sugino, Takeshi Shimizu, Yasushi Takeichi, Ryoji Ishiki, Haruo Inagaki, Yukio Ozaki, Toyoaki Murohara

Research output: Contribution to journalReview article

26 Citations (Scopus)

Abstract

Background-Although stent fracture (SF) after sirolimus-eluting stent (SES) implantation has been recognized as one of the predisposing factors of in-stent restenosis, it remains uncertain whether SF can increase the risk of major adverse cardiac events (MACE), especially beyond 1 year after SES implantation. The aim of this study was to assess the impact of SF relative to non-SF on 4-year clinical outcomes after treatment with SES of comparable unselected lesions. Methods and Results-A total of 874 lesions in 793 patients undergoing SES implantation and subsequent angiography 6 to 9 months after index procedure were analyzed. At 6- to 9-month angiographic follow-up, SF was identified in 70 of 874 lesions (8.0%). In-stent late loss was significantly higher in SF lesions versus non-SF lesions (0.42±0.59 mm versus 0.13±0.49 mm, P<0.001), resulting in a significantly higher in-stent restenosis rate (21.4% versus 4.1%, P<0.001). At 4 years, SF versus non-SF was associated with a significantly higher MACE rate (23.2% versus 12.6%, P=0.014), mainly driven by significantly higher target-lesion revascularization (18.8% versus 10.2%, P=0.029) rate. Adverse effects of SF on clinical outcomes occurred mostly within the first year (17.4% versus 6.6%, P=0.001), with similar MACE rate between 1 and 4 years (5.8% versus 5.9%, P=0.611). No significant differences between SF versus non-SF patients were observed in the cumulative frequency of very late stent thrombosis (2.9% versus 1.4%, P=0.281), death (0% versus 2.1%, P=0.252), or myocardial infarction (5.8% versus 2.9%, P=0.165). Conclusions-SF of SES was associated with higher MACE rate up to 1 year, mainly driven by higher target-lesion revascularization, whereas no significant association was evident between years 1 and 4.

Original languageEnglish
Pages (from-to)349-354
Number of pages6
JournalCirculation: Cardiovascular Interventions
Volume4
Issue number4
DOIs
Publication statusPublished - 01-08-2011

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Sirolimus
Stents
Causality

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Umeda, H., Kawai, T., Misumida, N., Ota, T., Hayashi, K., Iwase, M., ... Murohara, T. (2011). Impact of sirolimus-eluting stent fracture on 4-year clinical outcomes. Circulation: Cardiovascular Interventions, 4(4), 349-354. https://doi.org/10.1161/CIRCINTERVENTIONS.110.958306
Umeda, Hisashi ; Kawai, Tomoko ; Misumida, Naoki ; Ota, Tomoyuki ; Hayashi, Kazutaka ; Iwase, Mitsunori ; Izawa, Hideo ; Sugino, Shigeo ; Shimizu, Takeshi ; Takeichi, Yasushi ; Ishiki, Ryoji ; Inagaki, Haruo ; Ozaki, Yukio ; Murohara, Toyoaki. / Impact of sirolimus-eluting stent fracture on 4-year clinical outcomes. In: Circulation: Cardiovascular Interventions. 2011 ; Vol. 4, No. 4. pp. 349-354.
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title = "Impact of sirolimus-eluting stent fracture on 4-year clinical outcomes",
abstract = "Background-Although stent fracture (SF) after sirolimus-eluting stent (SES) implantation has been recognized as one of the predisposing factors of in-stent restenosis, it remains uncertain whether SF can increase the risk of major adverse cardiac events (MACE), especially beyond 1 year after SES implantation. The aim of this study was to assess the impact of SF relative to non-SF on 4-year clinical outcomes after treatment with SES of comparable unselected lesions. Methods and Results-A total of 874 lesions in 793 patients undergoing SES implantation and subsequent angiography 6 to 9 months after index procedure were analyzed. At 6- to 9-month angiographic follow-up, SF was identified in 70 of 874 lesions (8.0{\%}). In-stent late loss was significantly higher in SF lesions versus non-SF lesions (0.42±0.59 mm versus 0.13±0.49 mm, P<0.001), resulting in a significantly higher in-stent restenosis rate (21.4{\%} versus 4.1{\%}, P<0.001). At 4 years, SF versus non-SF was associated with a significantly higher MACE rate (23.2{\%} versus 12.6{\%}, P=0.014), mainly driven by significantly higher target-lesion revascularization (18.8{\%} versus 10.2{\%}, P=0.029) rate. Adverse effects of SF on clinical outcomes occurred mostly within the first year (17.4{\%} versus 6.6{\%}, P=0.001), with similar MACE rate between 1 and 4 years (5.8{\%} versus 5.9{\%}, P=0.611). No significant differences between SF versus non-SF patients were observed in the cumulative frequency of very late stent thrombosis (2.9{\%} versus 1.4{\%}, P=0.281), death (0{\%} versus 2.1{\%}, P=0.252), or myocardial infarction (5.8{\%} versus 2.9{\%}, P=0.165). Conclusions-SF of SES was associated with higher MACE rate up to 1 year, mainly driven by higher target-lesion revascularization, whereas no significant association was evident between years 1 and 4.",
author = "Hisashi Umeda and Tomoko Kawai and Naoki Misumida and Tomoyuki Ota and Kazutaka Hayashi and Mitsunori Iwase and Hideo Izawa and Shigeo Sugino and Takeshi Shimizu and Yasushi Takeichi and Ryoji Ishiki and Haruo Inagaki and Yukio Ozaki and Toyoaki Murohara",
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Umeda, H, Kawai, T, Misumida, N, Ota, T, Hayashi, K, Iwase, M, Izawa, H, Sugino, S, Shimizu, T, Takeichi, Y, Ishiki, R, Inagaki, H, Ozaki, Y & Murohara, T 2011, 'Impact of sirolimus-eluting stent fracture on 4-year clinical outcomes', Circulation: Cardiovascular Interventions, vol. 4, no. 4, pp. 349-354. https://doi.org/10.1161/CIRCINTERVENTIONS.110.958306

Impact of sirolimus-eluting stent fracture on 4-year clinical outcomes. / Umeda, Hisashi; Kawai, Tomoko; Misumida, Naoki; Ota, Tomoyuki; Hayashi, Kazutaka; Iwase, Mitsunori; Izawa, Hideo; Sugino, Shigeo; Shimizu, Takeshi; Takeichi, Yasushi; Ishiki, Ryoji; Inagaki, Haruo; Ozaki, Yukio; Murohara, Toyoaki.

In: Circulation: Cardiovascular Interventions, Vol. 4, No. 4, 01.08.2011, p. 349-354.

Research output: Contribution to journalReview article

TY - JOUR

T1 - Impact of sirolimus-eluting stent fracture on 4-year clinical outcomes

AU - Umeda, Hisashi

AU - Kawai, Tomoko

AU - Misumida, Naoki

AU - Ota, Tomoyuki

AU - Hayashi, Kazutaka

AU - Iwase, Mitsunori

AU - Izawa, Hideo

AU - Sugino, Shigeo

AU - Shimizu, Takeshi

AU - Takeichi, Yasushi

AU - Ishiki, Ryoji

AU - Inagaki, Haruo

AU - Ozaki, Yukio

AU - Murohara, Toyoaki

PY - 2011/8/1

Y1 - 2011/8/1

N2 - Background-Although stent fracture (SF) after sirolimus-eluting stent (SES) implantation has been recognized as one of the predisposing factors of in-stent restenosis, it remains uncertain whether SF can increase the risk of major adverse cardiac events (MACE), especially beyond 1 year after SES implantation. The aim of this study was to assess the impact of SF relative to non-SF on 4-year clinical outcomes after treatment with SES of comparable unselected lesions. Methods and Results-A total of 874 lesions in 793 patients undergoing SES implantation and subsequent angiography 6 to 9 months after index procedure were analyzed. At 6- to 9-month angiographic follow-up, SF was identified in 70 of 874 lesions (8.0%). In-stent late loss was significantly higher in SF lesions versus non-SF lesions (0.42±0.59 mm versus 0.13±0.49 mm, P<0.001), resulting in a significantly higher in-stent restenosis rate (21.4% versus 4.1%, P<0.001). At 4 years, SF versus non-SF was associated with a significantly higher MACE rate (23.2% versus 12.6%, P=0.014), mainly driven by significantly higher target-lesion revascularization (18.8% versus 10.2%, P=0.029) rate. Adverse effects of SF on clinical outcomes occurred mostly within the first year (17.4% versus 6.6%, P=0.001), with similar MACE rate between 1 and 4 years (5.8% versus 5.9%, P=0.611). No significant differences between SF versus non-SF patients were observed in the cumulative frequency of very late stent thrombosis (2.9% versus 1.4%, P=0.281), death (0% versus 2.1%, P=0.252), or myocardial infarction (5.8% versus 2.9%, P=0.165). Conclusions-SF of SES was associated with higher MACE rate up to 1 year, mainly driven by higher target-lesion revascularization, whereas no significant association was evident between years 1 and 4.

AB - Background-Although stent fracture (SF) after sirolimus-eluting stent (SES) implantation has been recognized as one of the predisposing factors of in-stent restenosis, it remains uncertain whether SF can increase the risk of major adverse cardiac events (MACE), especially beyond 1 year after SES implantation. The aim of this study was to assess the impact of SF relative to non-SF on 4-year clinical outcomes after treatment with SES of comparable unselected lesions. Methods and Results-A total of 874 lesions in 793 patients undergoing SES implantation and subsequent angiography 6 to 9 months after index procedure were analyzed. At 6- to 9-month angiographic follow-up, SF was identified in 70 of 874 lesions (8.0%). In-stent late loss was significantly higher in SF lesions versus non-SF lesions (0.42±0.59 mm versus 0.13±0.49 mm, P<0.001), resulting in a significantly higher in-stent restenosis rate (21.4% versus 4.1%, P<0.001). At 4 years, SF versus non-SF was associated with a significantly higher MACE rate (23.2% versus 12.6%, P=0.014), mainly driven by significantly higher target-lesion revascularization (18.8% versus 10.2%, P=0.029) rate. Adverse effects of SF on clinical outcomes occurred mostly within the first year (17.4% versus 6.6%, P=0.001), with similar MACE rate between 1 and 4 years (5.8% versus 5.9%, P=0.611). No significant differences between SF versus non-SF patients were observed in the cumulative frequency of very late stent thrombosis (2.9% versus 1.4%, P=0.281), death (0% versus 2.1%, P=0.252), or myocardial infarction (5.8% versus 2.9%, P=0.165). Conclusions-SF of SES was associated with higher MACE rate up to 1 year, mainly driven by higher target-lesion revascularization, whereas no significant association was evident between years 1 and 4.

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U2 - 10.1161/CIRCINTERVENTIONS.110.958306

DO - 10.1161/CIRCINTERVENTIONS.110.958306

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VL - 4

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JO - Circulation: Cardiovascular Interventions

JF - Circulation: Cardiovascular Interventions

SN - 1941-7640

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